Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21— 510(k) K160347

Name: FDA 510(k) clearance K160347
Creator: U.S. Food and Drug Administration
Published: 2016-03-03

Substantially Equivalent

Qingdao Hisense Medical Equipment Co., Ltd.

FDA 510(k) clearance K160347 for Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21, Substantially Equivalent on 2016-03-03. Applicant: Qingdao Hisense Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2016-02-08
Decision date: 2016-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qing Dao, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.